This position is ideal for someone with strong expertise in quality management systems who is ready to lead QMS initiatives and ensure compliance across digital health solutions.

This role is based in Basel, Switzerland, and can be offered on a full-time or part-time basis (80–100%). Applicants must hold a valid permit to work in Switzerland.

As Senior QMS Analyst, you will be responsible for the implementation and maintenance of the Quality Management System (QMS) for software either used in a regulated pharmaceutical trial environment, or as a medical device. 

This role ensures that product compliance and internal quality standards consistently align with global regulatory requirements and client expectations.

• Act as the primary point of contact for implementation and maintenance of the QMS as per ISO 13485, or other relevant standards focussing on core QMS processes, including:

  • CAPA and Nonconformance.

  • Complaints.

  • Change Management.

  • Document and Record Management.

  • Audit.

  • Supplier management.

  • Management Review.

• Develop and maintain essential quality documents, such as procedures, work instructions, and standard operating procedures (SOPs). 

• Ensure deviations are addressed appropriately.

• Coordination, and representation of the QMS, during external audits, vendor qualification, and regulatory inspections. 

• Supports Head of RA/QM with Quality Planning, Quality Objectives, Quality Manual. 

• Conduct internal audits and maintain supplier controls.

• Collaborate with ISMS manager where applicable, to integrate core processes in a unified QMS.

• Manage and coordinate the use of software tools and systems that support QMS best practices.

• Bachelor´s degree or higher in a relevant area.

• Certified internal auditor.

• GCP Basic understanding.

Needed skills:

• Ability to explain complex material in understandable language.

• >5 years experience in a highly regulated environment.

• >3 years in a QMS role.

• Experienced with performing internal audits.

• Previous experience with ISO 13485.

• Preferred: Good understanding of Pharma GMP.

• Pragmatic problem solving skills and drives continuous improvement.

• Eye for detail.

• Excellent writing skills and ability to transform text into graphical instructions.

Language Requirements: 

A high level of English proficiency is mandatory. Fluency in additional languages, especially Spanish, will be highly valued.